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NCT Number: NCT06645925

Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Posterior Mandibular Implant

Presence of keratinized tissue (KT) around dental implants, plays a crucial role in stability and health of peri-implant tissues. Several studies reported that, minimum of 2 mm keratinized tissue width is required to achieve long-term longevity. Insufficient keratinized mucosa leads to biofilm accumulation, soft tissue inflammation, eventually peri-implant mucositis and peri-implantitis. Hence, the aim of the present trial is to evaluate KTW gain, linear and volumetric changes in buccal soft tissue along with hard tissue alterations following implant restoration at sites treated either with delayed implant placement & simultaneous FGG or the conventional FGG protocol prior to implant placement.

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Key information

Conditions

Free Gingival Graft Free Gingival Graft Volume Change Keratinized Tissue

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Dental Continuing Education

Cairo, 11347, Egypt

Location status: Recruiting

Location contact

Ahmed Abou El Fetthouh, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults at or above the age of 18.
  • Lower Posterior missing tooth/ teeth with minimal KT < 2mm
  • Sufficient alveolar ridge length minimum 13-15 mm to IAN

•. Sufficient alveolar ridge width minimum of 6 mm

  • Patients able to tolerate surgical periodontal procedures.
  • Patients who provided an informed consent and accepted the one-year follow-up period.

Exclusion criteria

  • Patients diagnosed with periodontal diseases (Caton et al., 2018).
  • Current or previous smokers.
  • Pregnant and lactating females.
  • Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous Bisphosphonates for treatment of osteoporosis.
  • Patients with active infection related to the site of implant.
  • Patients with parafunctional habits.
  • Patients with shallow vestibule

Treatment and study plan

One Step Protocol

Procedure

FGG will be done simultaneous with implant placement

Two Steps Protocol

Procedure

Conventional FGG protocol, prior to implant placement

Primary outcomes

  1. Keratinized tissue width

    Time frame: 0 - 3 - 6 - 12 months

    Measure Clinically and Digitally at 0 - 3 - 6 - 12 months postoperative

Secondary outcomes

  1. Linear changes in buccal soft tissue contour

    Time frame: 0-3, 0-6, 0-12 Months

  2. Interdental Papilla height changes

    Time frame: 12 months

  3. Midfacial margin changes

    Time frame: 12 Months

  4. Crestal bone level changes

    Time frame: 12 Months

  5. Bone labial to the implant

    Time frame: 12 Months

  6. Survival Rate

    Time frame: 12 Months

Study contacts

Contact information is provided by the study sponsor or research team.

Nourhan G AbdelAziz, Masters degree periodontology

CONTACT

[email protected]

+00201064249441

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Collaborators

  • International Dental Contiuing Education

Registry information

Official study title

Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Implant Placement in Posterior Mandible: A 1-year Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 17, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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